Risk assessment

Endocrine disruptors

Biocides

SCHEER - Opinions 2016 - 2021

Preliminary Opinions open for comments / public consultation

The Opinions in this section have been developed by the SCHEER on the basis of a specific request (mandate) submitted by the Commission services. The Opinions have been recently approved and are now open for comments, for a period of minimum of 4 weeks.

The objective of public consultations is to gather specific comments and suggestions on the scientific basis of the opinion, as well as any other relevant scientific information regarding the questions addressed, in order to allow the Scientific Committees to focus on issues which need to be further analysed.

The comments received during the consultation period will be submitted to the SCHEER to be discussed and to finalise the Opinion.

Opinions being finalised

The public consultation / commenting period for this Opinion is over. Comments received are (currently) being examined by the SCHEER. The Opinion will be finalised as soon as possible.

In view of the new organisation of the Scientific Committees, namely the merger of two committees (SCHER and SCENIHR) to form the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER), the European Commission asked the SCENIHR first and then the SCHEER to produce a guidance document revising the structure and content of scientific Opinions and statements.

This document aims to provide guidance on how to ensure the high quality of the scientific Opinions and statements in dealing with human healthin dealing with human health in dealing with human health in dealing with human health, environmental and emerging risks.

The new structure is proposed as an annex to the guidance. It will be tested by the SCHEER for a period of approximately one year and after that, amended if necessary.

Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) hereby provides an inventory of new information available on the safety of Poly Implant Prothèse (PIP) silicone breast implants to evaluate whether an update of the 2014 SCENIHR Opinion on the safety of the PIP breast implants (2014 Opinion) is warranted.

In addition to conducting a literature review, a public call for scientific information was launched. The literature review showed that new information is available regarding the possible health effects of PIP breast implants, but this information is rather limited. Also, the public call for information did not result in the submission of scientific papers regarding health effects specific to PIP implants, but rather on breast implants in general. Therefore, on the basis of the new scientific information gathered, the SCHEER concludes that an update of the 2014 Opinion is not warranted.

New scientific information was found relating to the early and increased PIP implant rupture risk, which suggested that the risk was probably due to the low quality of the implant’s shell as already reported in 2014 Opinion. Based on new data, the rupture rate of PIP silicone breast implants was calculated to about 23%, which is similar to the 25% - 30% rupture rate indicated in the 2014 Opinion.

The SCHEER was requested by the European Commission to provide an advice on the state of scientific knowledge regarding a possible association between breast implants and anaplastic large cell lymphoma (ALCL) and determine whether sufficient scientific information was available for conducting a full risk assessment on a possible association between breast implants and ALCL.

The scientific literature search has retrieved mainly case reports and case series and, in addition, a few epidemiological studies. The available information suggests that breast implants may be associated with an increased risk for ALCL.

Although the very low incidence of ALCL and the methodological limitations of the available information/studies do not currently allow for a robust risk assessment, the SCHEER recommends that a more in-depth evaluation be conducted on the possible association of breast implants with the development of ALCL.

Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) reviewed recent evidence to update the 2009 Opinion of the Scientific Committee on Health and Environmental Risks (SCHEER) on ‘The need for non-human primates in biomedical research, production and testing of products and devices’.

This Opinion responds to six main issues in the mandate and highlights the many scientific approaches that could significantly contribute to the replacement, reduction and refinement (3Rs) of Non-Human Primates (NHP) studies and tests. However, there are significant issues that go beyond scientific rationale that prevent widespread adoption and development of alternatives for NHP laboratory use and these are discussed with suggestions of the opportunities to overcome them.

Although the current state of knowledge does not permit to propose a timetable for phasing-out the use of NHP in Europe, the Opinion provides recommendations on how to advance 3Rs for NHP use, such as through alternative methods, training, improvement of techniques and protocols, sharing of knowledge and removal of barriers. Finally, research needs are given.

SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Final Opinion on ‘The need for non-human primates in biomedical research, production and testing of products and devices (update 2017)’, 18 May 2017.

Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) reviewed recent evidence to assess potential risks to human health posed by Light Emitting Diodes (LEDs) emissions.

The review of the published research conducted by the SCHEER has led to valuable conclusions and identified certain gaps in knowledge on potential risks to human health from LEDs. The Committee concluded that there is no evidence of direct adverse health effects from LEDs emission in normal use (lamps and displays) by the general healthy population. There is some evidence that exposure to light in the late evening, including that from LED lighting and/or screens, may have an impact on the circadian rhythm. At the moment, it is not yet clear if this disturbance of the circadian system leads to adverse health effects.

Vulnerable and susceptible populations (young children, adolescents and elderly people) have been considered separately. Children have a higher sensitivity to blue light and although emissions may not be harmful, blue LEDs (between 400 nm and 500 nm) including those in toys may be very dazzling and may induce photochemical retinopathy, which is a concern especially for children below three years of age. Older people may experience discomfort from exposure to light that is rich in blue light.

Although there are cellular and animal studies showing adverse effects raising concerns, particularly in susceptible populations, their conclusions derive from results obtained either using exposure conditions that are difficult to relate to human exposures or using exposure levels greater than those likely to be achieved with LED lighting systems in practice. Some LEDs present potential health concerns due to temporal light modulation (flicker) at frequencies of 100 Hz and above.

Reliable information on the dose-response relationship for adverse health effects for the healthy general public is not available in the scientific literature for all wavelengths emitted by LED devices.

Since the use of LED technology is still evolving, the Committee considers that it is important to closely monitor the risk of adverse health effects from long-term LED use by the general population.

Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) reviewed recent evidence to assess health risks associated with UV-C radiation from lamps.The part of the ultraviolet radiation emitted in the wavelength range 280 nm–100 nm is called UV-C; this radiation is used in a growing number of applications, which include disinfection of water and air, food-industry processing, and air-conditioning. Although most appliances are sealed systems there is now increasing use of devices where consumers may be directly exposed to UV-C radiation.Based on the review and assessment of relevant scientific data, the SCHEER concluded that:

• Adverse effects to the eye and skin in humans are reported mainly from accidental acute exposure to high levels of UV radiation from UV-C lamps.

• Mechanistic studies suggest that there are wavelength-dependent exposure thresholds for UV-C regarding acute adverse effects to human eyes and skin, except for erythema. However, quantitative estimation of these thresholds could not be derived from currently available data.

• Due to the mode of action and induced DNA damage similarly to UVB, UV-C can be considered carcinogenic to humans. However, the currently available data do not allow quantitative cancer risk assessment of exposure from UV-C lamps.

• UV-C lamps emitting radiation at wavelengths shorter than 240 nm need additional risk assessment of the associated production of ozone in the environment. More data are needed on the exposure of general population and workers from UV-C lamps and generated ozone.

Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks reviewed recent evidence to update the 2006 Opinion of the Scientific Committee on Consumer Products on the Biological effects of ultraviolet radiation (UVR) relevant to health, with particular reference to sunbeds for cosmetic purposes. The term “sunbed” refers to all types of UV tanning devices used for cosmetic purposes.

UVR, including UVR emitted by sunbeds, is a complete carcinogen, as it acts both as an initiator and a promoter. The SCHEER concludes that there is strong evidence that exposure to UVR, including that emitted by sunbeds, causes cutaneous melanoma and squamous cell carcinoma at all ages and that the risk for cancer is higher when the first exposure takes place in younger ages. There is moderate evidence that exposure to UVR, including that emitted by sunbeds, also increases the risk of basal cell carcinoma and ocular melanoma.

The potentially beneficial effects of sunbed use such as generation of vitamin D are outweighed by the adverse effects. There is no need to use sunbeds to induce Vitamin D production.

There is no threshold level of UV-irradiance and UV–dose for the induction of skin cancer. Therefore, there is no safe limit for exposure to UV radiation from sunbeds.

The SCHEER was requested to assess public health risks resulting from onshore oil and gas exploration and extraction activities on a commercial scale in the EU, and to identify knowledge gaps.

Onshore oil and gas exploration and exploitation can induce increased human exposure to biocides, scale and corrosion inhibitors, oxygen scavengers, surfactants, and various hydrocarbons such as Volatile Organic Compounds (VOCs), polycyclic aromatic hydrocarbons (PAH), as well as particulate matter and noise in surrounding populations. Another consequence of onshore oil and gas exploration and exploitation relates to seismic activity: the level of evidence linking this phenomenon to onshore oil and gas exploration and extraction is moderate to strong.

Some of these environmental factors are recognised carcinogens or contribute to the risk of other chronic diseases such as cardiovascular or neurological illnesses.

Epidemiological studies have tried to characterise the possible impact of emissions from onshore oil and gas exploration and exploitation on human health; the vast majority of these studies are from outside the EU, generally the USA. They have relied on relatively imprecise exposure estimates, which is likely to lead to attenuation of dose-response functions. These studies indicate that the risk of haematological cancers and of preterm delivery may be higher in populations living around onshore oil and gas exploration and exploitation sites in comparison to populations living further away. The corresponding level of evidence is weak to moderate. A complete quantified risk assessment cannot be undertaken given the existing limited knowledge base but existing risk assessment studies show some coherence with the associations found in epidemiological studies.

The SCHEER is surprised at the very limited scientific assessment and monitoring of both the environment and people’s health near long-established onshore oil and gas exploration and exploitation sites in the EU, given the numerous studies conducted on similar American oil and gas exploration and exploitation activities and the amount of scientific evidence pointing towards possible adverse effects of these activities.

The review undertaken by the SCHEER suggests a number of knowledge gaps that could be addressed through the following actions:

- development of a centralised and harmonised inventory of all oil and gas exploration and exploitation sites in the EU;

- conduct of analytical and modelling studies that identify, quantify and characterise exposure mixtures and their levels in the vicinity of these sites;

SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Opinion on public health impacts and risks resulting from onshore hydrocarbon exploration and production in the EU, 30 November 2018.

Stemming from Tobacco Products Directive 2014/40/EU and from a previous SCENIHR Opinion (Tobacco Additives I), the Commission has established a priority list of 15 additives contained in cigarettes and roll-your-own tobacco subject to enhanced reporting obligations that is to be updated on a regular basis. For these additives included in the priority list, manufacturers and importers of tobacco products must carry out comprehensive studies.

In the second Opinion (Tobacco Additives II) the SCHEER was asked to provide guidance on the type and criteria for comprehensive studies, and the most suitable methodologies to be used for the first list of 15 priority additives and for future updated lists.

The SCHEER proposes a step-wise strategy as the most pragmatic and efficient way to proceed in the assessment of the toxic, and addictive effects as well as and characterising flavour properties and to minimise testing.

In addition, the SCHEER analysed major data gaps for the 15 additives included in the priority list of additives which generally relate to information on addictiveness and attractiveness, as well as on the identity of the pyrolysis products.

The European Commission asked the Scientific Committee on Health and Environmental Risks (SCHER) and its successor, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) a guidance document illustrating the procedure to be followed by the SCHEER for the provision of ad hoc rapid risk assessments in case of cross border chemical health threats.

The SCHEER has been tasked with coordinating the response in case of cross border chemical health threats to support the Commission, as laid down by Decision 1082/2013/EU on serious cross border threats to health. These threats include both manmade and naturally occurring events (e.g. chemicals released during an incident or during a volcanic eruption) that may have an impact on public health. The rapid risk assessment does not cover the wider effects on the environment.

This document presents the procedure to be followed by the SCHEER for the provision of such ad hoc rapid risk assessments.

Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) hereby reviews the currently available data on the toxicity of aluminium, taking into account the different tolerable intake levels for aluminium established by the European Food Safety Authority in 2008 and by the Joint FAO/WHO Expert Committee on Food Additives in 2011, and presents its recommendation for a tolerable intake level for aluminium based on most recent data that could be used to adapt the migration limits for aluminium in the Toy Safety Directive 2009/48/EC, taking into account the exposure to aluminium from sources other than toys.

The SCHEER is of the opinion that for the time being the study by Poirier et al. from 2011 is the fundamental study for the derivation of a health-based limit value. Using the NOAEL of 30 mg/kg bw/d from this study (based on neuro-developmental effects seen at 100 mg/kg bw/d) as the Point of Departure and applying the default assessment factor of 100, a tolerable daily intake (TDI) of 0.3 mg/kg bw/d is considered appropriate by the SCHEER for the calculation of migration limits for aluminium from toys.

The resulting migration limits for aluminium from toys, calculated according to the current legislation, which allocates 10% of the tolerable daily intake to toys, are 2250 mg aluminium/kg of dry, brittle, powder-like or pliable toy material, 560 mg aluminium/kg of liquid or sticky toy material and 28130 mg aluminium/kg of scraped-off toy material.

However, the SCHEER noted that exposure to aluminium from sources others than toys, in particular from diet, which is by far the major source of chronic exposure, may already exceed the reference value for tolerable weekly intake as derived by JECFA. Therefore, the SCHEER recommends that the additional exposure from toys should be minimised.

Keywords:

Scientific opinion, aluminium, toys, migration limit, exposure

Opinion to be cited as:

SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Final Opinion on Tolerable intake of aluminium with regards to adapting the migration limits for aluminium in toys. 28 September 2017.

Following a request from the Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) reviewed the Guidance Document No. 27: ‘Technical Guidance for Deriving Environmental Quality Standards’ prepared by a collaborative framework (the Common Implementation Strategy) for the Water Framework Directive. The SCHEER concludes that the overall scientific quality of the proposed changes is an improvement to the earlier 2011 version. The SCHEER has a number of comments where more practical guidance can be provided or where the current state of knowledge is still insufficient or where it is not being fully utilised.

Following a request from the Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) reviewed the report prepared by the European Commission Joint Research Centre on “Proposed EU minimum quality requirements for water reuse in agricultural irrigation and aquifer recharge".

The SCHEER concludes that, while the methodology chosen is appropriate and the report considers many important elements, the document is deficient in key details. The SCHEER recommends that the description of the methodology be extended and detailed guidance be provided on how minimum quality requirements should be derived. The SCHEER is of the opinion that, in its current form, the minimum quality requirements proposed provide insufficient protection both to environmental and human health.

SCHEER Statement on emerging health and environmental issues (2018)

According to the Commission Decision C(2015) 5383, the Scientific Committees shall draw the Commission's attention to specific or emerging problems which may pose a potential risk to consumer's safety, public health or the environment. The Scientific Committees review and evaluate relevant scientific data and assess potential risks. The SCHEER Committee provides opinions on questions concerning health, environmental and emerging risks.

The SCHEER statement on emerging health and environmental issues draws the Commission Services’ attention to 14 emerging issues in the non-food area that Committee members have identified as having a potential impact on human health and/or the environment in the future.

SCHEER Position Paper on Emerging Issues and the Role of the SCHEER (2018)

According to the Commission Decision C(2015) 5383, the Scientific Committees shall draw the Commission's attention to specific or emerging problems which may pose a potential risk to consumer's safety, public health or the environment. The Scientific Committees review and evaluate relevant scientific data and assess potential risks. The SCHEER Committee provides opinions on questions concerning health, environmental and emerging risks.

The position paper on emerging issues and the role of the SCHEER describes the methodology how SCHEER draws the attention of the European Commission services to emerging issues in the non-food area.

This Memorandum is focussed on how to use the weight of evidence approach (WoE) to conduct a risk assessment for stressors to which humans and/or the environment may be exposed. It is intended to complement the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) report on the identification of emerging issues and the work on the challenges in future risk assessment. The aim of this document is to support the use of the WoE, wherever appropriate, for the risk assessment activities of the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). In addition, it should support the consistency in the work of different EU bodies performing risk assessments. Scientific evidence consists of observations, experimental and model results and expert judgements that serve to support, refute, or modify a scientific hypothesis or theory. The search for relevant information and data for the SCHEER comprises of identifying, collecting and selecting possible sources of evidence in order to perform a risk assessment and/or to answer the specific questions being asked. According to the issue being addressed, the SCHEER may utilise data provided by the DG tasking the SCHEER, or provided by a third party (e.g. stakeholder reports, submissions such as confidential data provided by companies or applicants), reports and Opinions of other scientific, governmental or international bodies, scientific (peer-reviewed) publications, meta-analysis and systematic reviews or personal communications.

The WoE is an iterative process involving:

- Problem formulation- Identification, collection and selection of the possible sources of evidence- Assessment and weighing of individual lines of evidence- Integration of lines of evidence- Description of uncertainties- Conclusion and reporting

For each line of evidence, the criteria of validity, reliability and relevance need to be applied and the overall quality has to be assessed. Several tools for the analysis and description of uncertainties are presented. In the integration of the different lines of evidence, the strength of the overall evidence depends on the consistency and the quality of the results. The weighing of the total evidence should be presented in a standard format. A system is proposed that classifies results of analysis for human and environmental risks in terms of:

- Strong weight of evidence: Coherent evidence from a primary line of evidence (human, animal, environment) and one or more other lines of evidence (in particular mode/mechanistic studies) in the absence of conflicting evidence from one of the other lines of evidence (no important data gaps)- Moderate weight of evidence: good evidence from a primary line of evidence but evidence from several other lines is missing (important data gaps)- Weak weight of evidence: weak evidence from the primary lines of evidence (severe data gaps)- Uncertain weight of evidence: due to conflicting information from different lines of evidence that cannot be explained in scientific terms- Weighing of evidence not possible: No suitable evidence available